China's State Drug Administration approves application for new drug ® by Astellas Acostin

Today,
the http://Group of thePharmaceuticals (http:// announced that china's nationalDrug(http://Supervisory Authority on November 18 approved the listing of the(http://)of theof theof the ® (XTAND®I enzalute) for a symptomatic or mild symptoms of anti-chemotherapy for patients with out-of-treatment of prostate cancerThe approval was based on a phase 3 efficacy and safety study of Asian multi-country, randomized, double-blind, placebo-controlled outcomes conducted in patients with asymptomatic or mildly mild progressive metastatic prostate cancer (who, despite receiving ADT treatment, still developed disease progression), and a single-dose pharmacokinetic study (scenario 9785-CL-0013) conducted in Chinese volunteersHealth(http://The Asian PREVAIL study (also known as the 9785-CL-0232 study) assessed and compared the efficacy and safety of oral nzalamine (160 mg/day) with treatment with a placebo-combined gonadotropin (GnRH), or a double-sided testicular excision 　　Asian patients participated in the study, which included about 200 Chinese patients The findings are consistent with the global key 3 PREVAIL study conducted in the same target population 　　It has been shown that patients treated with Nzalamine have a significantly lower risk of progression of prostate-specific antigen (PSA) and are statistically significant (risk ratio of 0.38 (95% confidence interval: 0.27, 0.52), P 0.0001), psamolamine group with a median progression of 8.31 months, and placebo group with 2.86 months compared to placebo, enlucidal disease risk of disease dysedisease The risk was also significantly reduced and equally statistically significant, with a risk ratio (HR) of 0.31 (95% confidence interval: 0.20, 0.46; P 0.0001) , compared to the placebo group, the total survival of patients treated with nzzalea mylamine was significantly increased and the risk of death was reduced by 67% (HR 0.33, .95% confidence interval: 0.16, 0.67 ;P.05. 　　In terms of safety
The Asian PREVAIL study found that the safety of Nzalamine was broadly consistent with the results of clinical studies conducted in patients with previously metastatic resistant prostate cancer 　　In randomized placebo-controlled clinical trial (http:// , the most common adverse reactions in patients treated with Nzalaluamine were fatigue/fatigue, decreased appetite, redness, joint pain, dizziness/dizziness, high blood pressure, headache, and weight loss The incidence of these adverse reactions was higher than in the placebo group